Recall Enforment Report D-0100-2025
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 11-14-2024 for the product Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories The product was recalled due to cgmp deviations: presence of n-nitroso-duloxetine impurity above the recommended interim limit. The product was distributed in Pa, Oh, Pr and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0100-2025 | 11-14-2024 | 12-11-2024 | Class II | 23,490 bottles | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Ongoing |
D-0099-2025 | 11-14-2024 | 12-11-2024 | Class II | 37,916 bottles | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Ongoing |
D-0101-2025 | 11-14-2024 | 12-11-2024 | Class II | 8,561 bottles | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Ongoing |